The effect of a bile acid sequestrant on bile acid- and glucose metabolism in patients with impaired glucose tolerance.

• Conditions: diabetes mellitus type 2, bile acid metabolism

• Registration Number: NL-OMON24802
• Lead Sponsor: o

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 24

Inclusion Criteria

1. Male obese subjects with an impaired glucose tolerance or newly diagnosed type 2 diabetes mellitus (fasting glucose > 6,0 mmol/l);

2. Age 18-55 yr;

Exclusion Criteria

1. Medication known to interfere with glucose metabolism or bowel flora composition;

2. Severe hypertriglyceridemia or any other lipid metabolism disorder;

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoints are changes in bile acid composition.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints are changes in hepatic and peripheral insulin resistance (assessed by hyperinsulinemic euglycemic clamp at baseline and after 12 weeks), metabolic parameters (lipid profile, glycemic control) as well as changes in faecal microbiota, glucose and lipid content (assessed by analysing faeces samples). Finally, muscle and adipose tissue samples will be obtained to assess D2 mRNA and activity and phosphorylation status of the insulin signalling cascade.